- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02676050
Visualising c-MET and Activated Neutrophils in Lung Cancer (DUAL)
Exploratory Study to Optically Visualise Activated Neutrophils and the Proto-oncogene, c-MET, in Lung Cancer Using DUAL Colour Fibre-based Endomicroscopy
Study Overview
Status
Conditions
Detailed Description
The primary objective of this study is to directly deliver a microdose of two optical imaging agents to 20 patients with suspected or confirmed lung cancer to assess whether the agents can detect c-MET expression and neutrophil activity in human lung cancer.
The primary endpoint is to visualise the delivery of these imaging agents to assess imaging parameters in patients with suspected or diagnosed lung cancer using a novel delivery catheter, imaging fibre and fibre-based endomicroscopy system.
This protocol will involve two cohorts of patients; Cohort 1 will include patients scheduled for resection of their lung cancer and Cohort 2 will be patients with suspected inoperable stage 3/4 lung cancer scheduled for a diagnostic bronchoscopy followed by therapy. For both cohorts, eligibility will be verified by a clinical trial physician after written informed consent has been obtained.
Fibre-based endomicroscopy (FE) will be performed and up to 100μg of both optical imaging agents will be instilled during a bronchoscopy procedure. CT identified regions of architecturally normal lung in all participants will act as internal controls and will be used to compare the signal in normal and diseased lung tissue. Tissue samples taken from both cohorts will be collected for ex vivo validation including immunohistochemistry, zymography and genomic screening.
A cardiorespiratory exam, chest x ray and routine observations will be performed 4-6 hours following the administration of both imaging agents. All participants will be visited by a member of the research team 24 hours (± 4 hours) after dosing to ensure no adverse events were experienced. All participants in Cohort 1 will complete the study when the 24 hour assessment has been successfully completed and all adverse events have been resolved. Participants in Cohort 2 will be invited back for a second bronchoscopy following the first round of their therapy to investigate whether the expression of c-MET or the level of neutrophil activity has changed. All participants in Cohort 2 will complete the study when the second 24 hour assessment has been successfully completed and all adverse events have been resolved.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Annya M Smyth, PhD
- Phone Number: 0131 242 9180
- Email: Annya.Smyth@ed.ac.uk
Study Contact Backup
- Name: Kev Dhaliwal, MBChB
- Phone Number: 01312429180
- Email: Kev.Dhaliwal@ed.ac.uk
Study Locations
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-
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Edinburgh, United Kingdom, EH16 4TJ
- Royal Infirmary of Edinburgh
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
INCLUSION CRITERIA FOR COHORT 1 • Patients undergoing cardiothoracic surgery for resection of lung cancer
INCLUSION CRITERIA FOR COHORT 2
• Patients with inoperable stage 3 or 4 lung cancer
INCLUSION CRITERIA FOR BOTH COHORTS
- ≥ 16 years
- Provision of informed consent from the patient prior to any study related procedures.
- Normal electrocardiogram (ECG)
- Forced Expiratory Volume (FEV1) >1L
- Thoracic CT scan taken in the last 20 weeks
- Attending consultant permission for bronchoscopy
- Readily accessible target areas with bronchoscopy and FE
EXCLUSION CRITERIA
- Refusal for participation by attending consultant
- Unsuitable for bronchoscopy
- Any history of anaphylaxis
- Significant coagulopathy, which causes bronchoscopy to be unsuitable, as determined by clinical co-investigator or the participant's attending consultant, using information which is routinely available
- Myocardial infarction in the preceding four weeks
- Women who are pregnant or are breastfeeding
- Receiving drugs that cause increased autofluorescence in the lung, specifically amiodorane and methotrexate
- Oxygen saturation <92% breathing room air
- Platelet count < 50 x 109/L
- Bleeding diathesis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Imaging agents and imaging devices
All participants in Cohort 1 will be dosed on one occasion with the optical imaging agents and Cohort 2 can be dosed twice per agent.
The final dosage will be <100ug per agent.
The agents will be delivered using a novel delivery catheter and imaged with a novel imaging fibre and microendoscopy system.
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Both optical imaging agents (NAP and EMI-137) will be administered to each patient during a bronchoscopy procedure.
A novel delivery catheter (to deliver both agents), imaging fibre and endomicroscopy system with viewer software will be used to detect c-MET and activated neutrophil signal in the human lung.
Other Names:
Both optical imaging agents (NAP and EMI-137) will be administered and imaged simultaneously during a bronchoscopy procedure using the devices mentioned above.
The signal emitted by both optical imaging agents (NAP and EMI-137) will be visualised using a novel endomicroscopy system.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The measurement of optical agents in the lung
Time Frame: On average, fluorescence signal can be detected within 5 minutes following optical imaging agent administration.
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The primary endpoint of this clinical investigation is to image the delivery of the optical imaging agents in human lung cancer using a novel delivery catheter, imaging fibre and fibre-based endomicroscopy system.
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On average, fluorescence signal can be detected within 5 minutes following optical imaging agent administration.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantification of signal of imaging agents
Time Frame: On average, fluorescence signal can be detected within 5 minutes following optical imaging agent administration.
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To determine whether neutrophil activation and c-MET activity are increased in human lung cancer in vivo in situ
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On average, fluorescence signal can be detected within 5 minutes following optical imaging agent administration.
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Ability of novel device to deliver agents and image simultaneously
Time Frame: Within 5 minutes
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To determine if the novel delivery catheter can co-deliver imaging agents and image simultaneously
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Within 5 minutes
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Whether expression correlates with treatment response
Time Frame: Within 4-6 weeks following first round of therapy
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To establish if neutrophil activity and c-MET upregulation can predict stage 3/4 tumour response to either chemotherapy or radiotherapy (Cohort 2).
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Within 4-6 weeks following first round of therapy
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kev Dhaliwal, MBChB, University of Edinburgh
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DUAL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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